All of Us℠

Research Program

From Design to Dissemination: An Opportunity for Women’s Health

Robert A. Winn, MD

Associate Vice Chancellor of Health Affairs, CBP

Director of UI Cancer Center

Jesse Brown VAMC

Illinois Precision Medicine Consortium, Multi PI

Overview of the All of Us Research Program

The Vision of President Obama:

“My hope is that this becomes the foundation, the architecture, whereby in

10 years from now we can look back and say that we have revolutionized

medicine.”- President Barack Obama

An initiative that was created FOR the people

All of Us Research Program: Director Eric Dishman

“As someone who has personally

benefited from precision medicine, I am

excited for this study to intersect with

other fundamental changes in medicine

and research to empower people to live

healthier lives.”

Eric Dishman

All of Us Research Program Director

All Of Us Research Program : DJ TIMBUCK2

⦿ The cornerstone of the larger PMI – ledby the NIH

⦿ One million or more volunteers,reflecting the broad diversity of the U.S.

⦿ Opportunities for volunteers to providedata on an ongoing basis

⦿ Data shared freely and rapidly to informa variety of research studies

The All of Us Research Program

Traditional Way: Bring data

to researchers

Data

Problems

• Security (data handoffs)

• Data sharing = data copying

• Huge infrastructure needed

• Fixed amount of compute

PMI Way: Bring researchers

to the data

Public Cloud

Advantages

• Threat detection and

auditing

• Cost

• Increased Accessibility

• Elastic compute

A Transformational Approach to Diversity

Reflecting the country’s rich diversity to

produce meaningful health outcomes for

communities historically underrepresented

in biomedical research

A Transformational Approach to Data Access

⦿ Data sharing will be a priority to both

researchers and participants

⦿ Participants will have access to study

information and data about themselves

⦿ Data collection will start small and will

grow over time

⦿ Privacy and security will adhere to the

highest standards

⦿ Will invest to level the playing field so

diverse researchers can play

HEALTH CARE PROVIDER ORGANIZATIONS DIRECT VOLUNTEERS

Two Methods of Engagement

Vs.

All of Us Research Program Data

The Program will start by collecting a limited set of

standardized data from sources that will include:

• Participant questionnaires

• Electronic health records

• A baseline physical evaluation

• Biospecimens (blood and urine samples)

• Mobile/wearable technologies

• Geospatial/environmental data

Data types will grow and evolve with science,

technology, and trust.

The Value of Participating in All of Us

⦿ A chance to learn some of your own health

indicators and get your own data

⦿ An opportunity to fight disease and improve

the health of future generations

⦿ An opportunity to ensure that your

community is included in the studies that

lead to new understanding and new treatments

⦿ The chance to be part of a movement, to

make our healthcare more precise, more

personal, and more effective

Program Status

BIOBANK

Mayo Clinic

HEALTH CARE PROVIDER

ORGANIZATIONS (HPOs)

Regional Medical Centers, Health Centers

(including Federally Qualified Health Center pilots),

VA Medical Centers

DATA AND RESEARCH

CENTER (DRC)

Vanderbilt University Medical Center

with the Broad Institute and Verily

PARTICIPANT TECHNOLOGIES

CENTER (PTC)

Scripps Research Institute

with Vibrent Health

Established Program Infrastructure

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Data and Research Support Center (DRSC)

⦿ Led by Vanderbilt, Verily, and Broad

⦿ Collaborators: Columbia, Northwestern, University of Michigan, University of Texas

Health Science Center at Houston

⦿ To acquire, organize, and provide secure access to the PMI Cohort Program datasets

⦿ To provide research support for the scientific data and analysis tools for the program,

helping to build a vibrant community of researchers who can propose studies

using this information

Biobank

⦿ Led by Mayo Clinic

⦿ To support the collection, analyses, storage, and distribution of biospecimens for

research use

Participant Technologies Center (PTC)/Direct Volunteer Operations

⦿ Led by Scripps Research Institute and Vibrent Health

Collaborators: PatientsLikeMe, Sage Bionetworks, Walgreens

⦿ Coordinate all direct volunteer enrollment and engagement activities

⦿ Develop mobile applications and other technologies to collect data from and

communicate with participants

HPOs: Regional Medical Centers

Columbia, Cornell, Harlem Hospital , and NewYork-Presbyterian

Illinois Precision Medicine Consortium (Northwestern, Univ. of Chicago, and Univ. of Illinois at Chicago, et al.)

University of Pittsburgh

University of Arizona and Banner Health

Initial awardees, July 2016

Illinois Precision Medicine Consortium: IPMC

Phil Greenland, MD

Abel Kho, MD

Robert A. Winn, MD

Martha Diviglius, MD, PhD

Denise Hynes, PhD

Habibul Ahsan, MD

Karen Kim, MD

Illinois Precision Medicine Consortium

• Northwestern University

• University of Illinois at Chicago

• University of Chicago

• University of Illinois at Chicago, Peoria

• Cook County Health and Hospitals

• NorthShore University HealthSystem

• OSF Saint Francis Medical Center

• Rush University Medical Center

• Sinai Health System

• SIU Healthcare; Memorial Medical Center;

Blessing Health System; Sarah Bush Lincoln

HPOs: Federally Qualified Health Centers (FQHCs)

⦿ Develop and pilot community health center approaches for enrolling underserved

populations, especially those historically underrepresented in biomedical research

⦿ A collaboration with the Health Resources and Services Administration (HRSA) and

the MITRE Corporation

Collaboration with Department of Veterans Affairs

⦿ Strategic partners to learn from/with

⦿ VA medical centers to help enroll veterans

⦿ Million Veteran Program:

A national, voluntary research program studying how genes affect

health; participants to be invited to enroll in the PMI Cohort

Program as well

Illinois Precision Medicine Consortium Pitt

Pittsburgh,

PA

U of A (w/ Banner Health)Tucson, AZ

Columbia Uni. Health Sciences(with Harlem Hospital, Weill Medical

College of Cornell, and New York-

Presbyterian)

New York, NY

Calif PM ConsortiumSan Diego, CA

New Eng PM ConsortiumBoston, MA

Trans-AmerPM Consort for HCSRNsDetroit, MI

GeisingerDanville, PABiobank

Mayo Clinic,

Rochester, MN

PTCScripps, La Jolla, CA

DRCVanderbilt, Nashville,

TN

FQHCs

RMCs

National Partners

Hudson River Peekskill, NY

Cherokee HealthKnoxville, TN

Eau ClaireColumbia, SC

San Ysidro

HealthSan Ysidro, CA

Jackson-HindsJackson, MS

Community Health Middletown, CT

National Network of Inaugural Partners

Federal Partners: White House, HHS, NIH, ONC, HRSA, VA, USDSWashington, D.C. area

⦿ Ambien (zolpidem)

⦿ Women eliminated Ambien more slowly then men (metabolized in liver)

⦿ Associated with women potentially having increased driving accidents

⦿ The U.S. Federal Drug Agency strongly recommended halving the dose of Ambien in women

⦿ Treatment with lower dose Ambien (5mg) had the same benefit for women as the standard higher doses (10mg) for men

GEOGRAPHY

Geography Matters (Zip code vs. Genetic code): The Tale of Two Sisters

• Two sisters

• Raised together in the same town

• The same home

• Under the same circumstances

• Subsequently grow up and move

apart

The city of Chicago; e.g. Gold Coast

• Is very affluent (higher income)

• It has access to the lake front, gyms, parks

• Many farmers markets and fresh food markets

• Top universities, hospitals, etc.

The city of Moline

• High poverty rate (lower income)

• High incidence rate and mortality of Breast Cancer

• Lack of access to fresh foods

• Lack of access to top universities, hospitals, etc.

Geography Matters (Zip code vs. Genetic code)

Geography Matters (Zip code vs. Genetic code): The Tale of Two Sisters

• They both develop breast cancer

• Will the treatment be the same for

both sisters

• How does what they eat affect their

treatment (e.g. microbiome)

• How will the everyday stresses they

have to live with affect their treatments

(e.g. epigenetics)

SOCIAL DETERMINANTS OF HEALTH

• HEALTH CARE

• HOUSING

• EDUCATION

• FOOD

• BUILT ENVIRONMENT

• POLLUTION

• COMMUNITY AND DOMESTIC VIOLENCE

• CRIMINAL JUSTICE

• EMPLOYMENT

• GOVERNANCE

FOOD DISPARITIES IN CHICAGO

Food Disparities and BMI in Chicago

From “Big Data” to “Precise Data”

“Old” Model

•Based on “BIG DATA”

•Little to no “community input”

Develop Cancer Screening Program

• Model depends on patients coming “TO” clinics

• Programs done “TO” patients and not “FOR” patients

Implement Cancer Screening Program • Patients in mostly

underserved communities diagnosed at “LATE STAGE”

• Late Stage Diagnosis MORE COSTLY than early stage diagnosis

Outcomes: Late Stage Cancer

Diagnosis

“Precise” Data Driven Model

•Based on data at “relevant level”

Ongoing Input from political, community, clinical and academic partners

Develop Cancer Screening Program

• Model supports screening WITHIN the community clinics

Screening done “FOR” patients and not “TO” patients

Implement Cancer Screening Program • Early Stage Diagnosis

Cost savings for Early Stage Diagnosis

Outcomes: Early Stage Cancer

Diagnosis

Empowering Women from All Communities to Be a Part of the Conversation

•Health Determinants of our Zip codes vs our Genetic Code.

• If we aren’t at the table we end up on the menu.

•Clinical Trials • Non participation widens the gap of

health disparity.

• Participation ensures miracle drugs are created with ____ in mind.

• Creation of drugs that will benefit future generations.

•To move from having things done “to” us as opposed to “for” us, we have to begin doing things “with” them.

HOPE for All of Us

All of Us℠

Research Program

An Introduction to the

Questions?

https://www.nih.gov/precision-medicine-initiative-cohort-program

Email: precisionmedicine@od.nih.gov

THE PUBLIC HEALTH CRISIS

September 2015

• Dr. Mona Hanna-Attisha warns Flint to stop using Flint River

• Dr. Marc Edwards reports on lead leaching into water supply

October 2015

• Flint city officials urge residents to stop drinking water

• MDEQ Reports inappropriate use of corrosion control

January 2016

• President Obama and Governor Snyder declare emergency

• Blizzard of 2016 - The Congressional Response Effort Begins

RED-LININGHome Owner’s Loan Corporation (1933-1935)

• 4 - Tiered assessment

• Measured sale and rental demand, % ownership, social status of population, utilities, schools, churches, business, transportation

• GRADES

• A – Green “hot spots”

• B – Blue “developed”

• C – Yellow “aged”

• D – Red “undesirable population”

PMI Cohort Program Major Components

• Data and Research Support Center (DRSC)

• Biobank

• Participant Technologies Center (PTC)

• Healthcare Provider Organizations (HPOs)

o Regional Medical Centers

o Community Health Centers (Federally Qualified

Health Centers)

o VA Medical Centers

Data and Research Support Center

⦿ Develop questionnaires for participant-provided information

⦿ Finalize all IT interfaces with biobank, PTC, and HPOs

⦿ Prepare and test transfer of electronic health records (EHRs)

from HPOs

⦿ Conduct security testing and gain authority to operate

Sign up for updates:

https://www.nih.gov/allofus-research-program

Questions?

43

Biobank

⦿ Finalize blood and urine collection protocols for HPOs and

direct volunteers

⦿ Finalize collection kits

⦿ Develop the capacity for an orderable test to be implemented

at all sites

⦿ Pilot test receiving samples from all sites

Participant Technologies Center & Direct Volunteer Operations

⦿ In collaboration with the direct volunteer pilot, get IRB

approval on program protocol

⦿ Conduct security testing and gain authority to operate

⦿ Develop website and apps for direct volunteer enrollment

⦿ Finalize processes for direct volunteer enrollment

⦿ Stand up call center

Sinai Health System

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Proposed Participant Enrollment

SHS IPMC Overall

Year 1 174 10,000

Year 2 624 35,000

Year 3 624 35,000

Year 4 624 35,000

Year 5 624 35,000

2,670 150,000

UI Health is now One of 8 Regional Medical Centers Awarded

• Able to enroll diverse

patient populations

• Strong electronic health

record capacity

• Geographic spread

• Capacity to enroll 35,000

a year

Illinois Precision Medicine Consortium Northwestern, U of C, and UIC

Chicago, IL

University

of PittsburghClinical and Translational

Science Institute

Pittsburgh, PA

University

of ArizonaCollege of Medicine

& Public Health

Tucson, AZ

Columbia

University Institute for Genomic

Medicine

New York, NY

University

of California

San DiegoDepartment of

Biomedical Informatics

La Jolla, CA

Massachusetts

General HospitalGenetics & Genomics Unit

Boston, MA

Henry Ford

Health SystemPublic Health Sciences

Detroit, MI

All of UsSM | The Precision Medicine Initiative®

HPOs: FQHC Pilot Sites

Hudson River Health CarePeekskill, NY

Cherokee Health SystemsKnoxville, TN

Eau Claire Cooperative Health CenterColumbia, SC

San Ysidro Health CenterSan Ysidro, CA

Jackson-Hinds Comprehensive Health CenterJackson, MS

Community Health Center, Inc.Middletown, CT

Initial sites selected July 2016More to come

All of Us Research Program

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https://wdrv.it/782dcafcd

[Not for public release]

Why Person Based Precise Medicine Matters

⦿ Lipitor (atorvastatin)

⦿ Cytochrome p450 (a drug metabolizing enzyme)

⦿ Too much of a good thing lead to toxicity in asian populations

⦿ Treatment with low dose statin has the same cardiovascular benefit of reducing heart disease (i.e. coronary artery disease) in Asians as the standard higher doses in Caucasians